Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Transitional Tobacco Care Management (TTCM); Behavioral: eReferral to State Tobacco Quitline (QL); Drug: Nicotine replacement therapy

• Registration Number: NCT03603496
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.

Detailed Description

This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-27
• Study Start: 2018-09-01
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Results First Submitted: 2022-02-24
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Results First Posted: 2022-05-05
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1416

Inclusion Criteria

• 18 years of age or older
• Current cigarette smoker (>=1 cigarette in the week before admission and >=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
• Admitted to a study hospital
• Seen by hospital smoking counselor during inpatient stay
• Plans to try to quit smoking after hospital discharge

Exclusion Criteria

• Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
• Life expectancy <12 months
• Medical instability
• No reliable telephone access or inability to use telephone
• Non-English speaking
• Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transitional Tobacco Care Management (TTCM)	Transitional Tobacco Care Management (TTCM)	TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
Transitional Tobacco Care Management (TTCM)	Nicotine replacement therapy	TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
eReferral to State Tobacco Quitline (QL)	eReferral to State Tobacco Quitline (QL)	Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.
eReferral to State Tobacco Quitline (QL)	Nicotine replacement therapy	Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.

Primary Outcome Measures

Name	Time	Method
Tobacco Abstinence, Biochemically Confirmed	6 months after hospital discharge	Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm.

Secondary Outcome Measures

Name	Time	Method
Tobacco Abstinence, Self-report	6 months after hospital discharge	Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
Engagement in Cessation Treatment	3 months after hospital discharge	Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge	6 months follow-up	Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge

Trial Locations

Locations (3)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States